Gupta Vishnu D
University of Houston, Houston, Texas.
Int J Pharm Compd. 2010 Jan-Feb;14(1):76-7.
The chemical stability of hydrocortisone in two different commercially available vehicles for compounding oral liquid dosage forms has been studies using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. Hydrocortisone was more stable in Ora-Sweet vehicle than in Humco simple syrup. After 71 days of storage at 60 degrees Celsius, the percent of hydrocortisone retained in Humco simple syrup was 62.8 ( initial pH value of the dosage form was 5.2) versus 67.7 in Ora-Sweet vehicle (initial pH value of the dosage form was 4.3). Due to the hydrolysis of sugar, the physical appearances of both the dosage forms gradually changed from almost colorless to yellow. Citric acid, which was present only in the Ora-Sweet vehicle, did not adversely affect the stability of hydrocortisone.
使用我们实验室开发的一种稳定性指示高效液相色谱分析方法,研究了氢化可的松在两种不同的市售用于配制口服液体制剂的赋形剂中的化学稳定性。氢化可的松在Ora-Sweet赋形剂中比在Humco单糖浆中更稳定。在60摄氏度下储存71天后,氢化可的松在Humco单糖浆中的保留率为62.8%(剂型的初始pH值为5.2),而在Ora-Sweet赋形剂中为67.7%(剂型的初始pH值为4.3)。由于糖的水解,两种剂型的外观都逐渐从几乎无色变为黄色。仅存在于Ora-Sweet赋形剂中的柠檬酸对氢化可的松的稳定性没有不利影响。